药品名称INDERAL
申请号016418产品号010
活性成分PROPRANOLOL HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1982/10/18申请机构WYETH PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
016418080APLabel2011/03/22下载
016418080APLetter2011/03/23下载
016418079APLetter2008/05/09下载
016418078APLabel2007/09/07下载
016418078APLetter2007/09/07下载
016418077APLetter2007/03/06下载
016418076APLetter2007/01/08下载
016418073APLetter2004/08/25下载
016418073APLabel2004/08/25下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
016418080AP2011/03/17Labeling Revision
016418079AP2008/05/06Labeling Revision
016418078AP2007/09/06Labeling Revision
016418077AP2007/02/21Labeling Revision
016418076AP2006/12/29Labeling Revision
016418073AP2004/08/18Labeling Revision
016418072AP2002/02/06Labeling Revision
016418071AP1999/08/22Labeling Revision
016418070AP1997/11/07Labeling Revision
016418069AP1990/02/15Labeling Revision
016418068AP1989/03/30Expiration Date Change
016418067AP1988/05/25Package Change
016418066AP1987/01/20Control Supplement
016418064AP1985/10/09Expiration Date Change
016418063AP1985/02/28Package Change
016418062AP1984/12/20Control Supplement
016418061AP1985/02/25Package Change
016418058AP1984/05/21Formulation Revision
016418057AP1985/02/22Manufacturing Change or Addition
016418056AP1984/01/12Control Supplement
016418055AP1985/06/18Control Supplement
016418054AP1983/01/21Labeling Revision
016418053AP1983/01/07Control Supplement
016418052AP1982/11/12Formulation Revision
016418051AP1986/10/31New or Modified Indication
016418049AP1982/10/18Labeling Revision
016418048AP1982/10/18General Efficacy (MarkIV)
016418047AP1983/09/30General Efficacy (MarkIV)
016418046AP1982/02/08Control Supplement
016418045AP1981/10/15Manufacturing Change or Addition
016418044AP1986/10/31New or Modified Indication
016418043AP1982/01/26Labeling Revision
016418041AP1983/03/21Manufacturing Change or Addition
016418039AP1980/09/19Control Supplement
016418038AP1980/09/16Control Supplement
016418037AP1980/03/24Package Change
016418036AP1980/03/24Formulation Revision
016418035AP1986/10/31New or Modified Indication
016418034AP1979/03/07Control Supplement
016418033AP1979/03/21Control Supplement
016418032AP1979/05/03Formulation Revision
016418031AP1979/02/12Control Supplement
016418030AP1978/08/03Package Change
016418029AP1978/12/12Labeling Revision
016418028AP1978/02/14Package Change
016418027AP1978/04/24Control Supplement
016418026AP1978/04/24Package Change
016418025AP1979/01/17General Efficacy (MarkIV)
016418024AP1979/03/07Labeling Revision
016418023AP1977/12/08Package Change
016418022AP1977/11/03Control Supplement
016418021AP1976/09/21Control Supplement
016418020AP1978/08/21Labeling Revision
016418016AP1975/02/18Labeling Revision
016418000AP1967/11/13Approval